ClinicalTrials.gg
Status unknownNCT04071145Updated Aug 28, 2019

Using Sensors to Measure Drug Concentrations in Exhaled Breath

An observational study in Mental Disorder, sponsored by Nadav Goldental. Status unknown. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by Nadav Goldental · Observational

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 100 Years
Sex
All
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Study summary

The use of blood tests to measure drug concentrations in psychiatric patients is often a crucial part of monitoring and evaluating the course of treatment. Such tests are commonly conducted as part of official protocols, and patients are often tested on a weekly basis.

The current study aims to examine the possibility of using a novel, non-invasive device to measure drug concentrations in exhaled breath as an alternative to blood tests. The device, SniffPhone, uses sensors to detect and measure volatile organic compounds (VOCs) in exhaled breath, and features a small and portable design. Sniff Phone has been previously approved for use in clinical trials and has been used successfully to screen for particular types of cancer and other diseases.

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Conditions studied

  • Mental Disorder

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In context

Mental Disorders

2,148 studies on the registry are indexed under Mental Disorders; 425 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 488 observational studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Nadav Goldental is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Psychiatric patients with traetment plans that require theraputic drug monitoring

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Proper ability to give informed consent
  • Psychiatric patients undergoing treatment at Sheba Medical Center
  • Patients with treatment plans that require therapeutic drug monitoring

Exclusion criteria

Exclusion Criteria:

  • Involuntary psychiatric hospitalization
  • Pregnancy
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Detection of drug type and concentration in volatile organic compounds (VOCs) profile

    Detection of drug type and concentration in VOCs profile (measured using Sniff Phone)

    Time frame: Up to 6 months

  2. Correlation between drug concentration and volatile organic compounds VOC concentrations

    Correlation between drug concentration (as measured in blood test) and VOCs (hexanone acetic acid, heptane, hexanal, 3-heptanone, hexanoic acid, heptanal and nonanal) measured using Sniff Phone.

    Time frame: Up to 6 months

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Study locations

No study locations are listed for this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2019; primary completion for Apr 2020, 7 months later.

Of 188 non-industry observational studies under Mental Disorders, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 72. This study's planned 7 months is below that.

Counting every sponsor, half of 193 studies reached it within 42 months; a quarter within 17 and three quarters within 94.

Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2019
First posted
Aug 28, 2019
StartEst.
Sep 2019
Primary completionEst.
Apr 2020
CompletionEst.
Oct 2020
Last update
Aug 28, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04071145
Lead sponsor
Nadav Goldental
Responsible party
Nadav Goldental (Principal investigator, The Chaim Sheba Medical Center) — Sponsor-investigator
First posted
Aug 28, 2019
Start date
Sep 2019 (estimated)
Primary completion
Apr 2020 (estimated)
Completion
Oct 2020 (estimated)
Last update
Aug 28, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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